LTR 153: Sherita Black on Building a Practical Policy for Risk Acceptability

Podcast: Let's Talk Risk! Podcast · Where MedTech professionals gain clarity and confidence to navigate complex decisions.

Opublikowano: 2026-05-01

Summary “Just having a policy in place is one thing. Having a QMS that aligns to it is the next.” In this Let’s Talk Risk! conversation, host Naveen Agarwal speaks with Sherita Black about one of the most challenging and often misunderstood topics in ISO 14971: creating a policy for risk acceptability. The conversation goes beyond the standard’s wording and gets into the practical questions that many teams struggle with: who top management really is, how to involve them, and how to turn policy into something that actually drives decisions. Sherita brings a strong...